K Number
K232777
Device Name
FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)
Date Cleared
2024-07-01

(294 days)

Product Code
Regulation Number
878.4040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FLUIDSHIELD* 1 Procedure Mask(s) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intention control practices to reduce the potential exposure of the wearer to blood and body fluids. FLUIDSHIELD* 1 Procedure Mask(s) are single use, disposable device(s), provided non-sterile.
Device Description
The subject devices are ASTM F2100 Level 1 (lavender in color) Procedure Masks. The ASTM F2100 Level 1 Procedure Mask family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868) includes a malleable nosepiece. The FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) includes a visor and nose foam. These masks are single use, disposable devices, provided non-sterile.
More Information

Not Found

No
The device is a procedure mask, and the summary describes its physical properties and performance in standard tests for masks. There is no mention of AI or ML.

No
The device is a procedure mask intended to protect against transfer of microorganisms, body fluids, and particulate material, not to treat or cure a disease or condition.

No

This device is a procedure mask intended to protect against the transfer of microorganisms, body fluids, and particulate material. It is not designed to diagnose any condition or disease.

No

The device description clearly states it is a three-layer mask constructed of non-woven materials, including a malleable nosepiece and potentially a visor and nose foam, indicating it is a physical hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the mask is for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
  • Device Description: The description details the physical construction and materials of the mask, consistent with a personal protective equipment (PPE) device.
  • Performance Studies: The performance studies focus on the mask's ability to filter particles and fluids, breathability, flame resistance, and biocompatibility. These are all relevant to a barrier device, not an IVD.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.

Therefore, the FLUIDSHIELD* 1 Procedure Mask is a medical device, but it falls under the category of personal protective equipment (PPE) and is not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The FLUIDSHIELD* 1 Procedure Mask(s) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intention control practices to reduce the potential exposure of the wearer to blood and body fluids. FLUIDSHIELD* 1 Procedure Mask(s) are single use, disposable device(s), provided non-sterile.

Product codes (comma separated list FDA assigned to the subject device)

FXX

Device Description

The subject devices are ASTM F2100 Level 1 (lavender in color) Procedure Masks. The ASTM F2100 Level 1 Procedure Mask family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868) includes a malleable nosepiece. The FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) includes a visor and nose foam. These masks are single use, disposable devices, provided non-sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

No clinical testing was performed in support of this submission.
Summary of Non-Clinical Testing:

  • ASTM F2101: Purpose To demonstrate adequate bacterial filtration efficiency; Criteria Under the conditions of the study, at least 95% efficiency; Result Pass
  • EN 14683:2019+AC Annex C: Purpose To demonstrate acceptable breathability; Criteria Under the conditions of the study, at most 5.0 mm H2O/cm²; Result Pass
  • ASTM F2299: Purpose To demonstrate adequate particulate filtration efficiency; Criteria Under the conditions of the study, at least 95% efficiency; Result Pass
  • ASTM F1862: Purpose To demonstrate adequate resistance to liquids; Criteria Under the conditions of the study, passing at 80 mmHg conditions; Result Pass
  • 16 CFR 1610: Purpose To evaluate flame spread resistance; Criteria Class 1 under the conditions of the testing; Result Pass
  • ASTM F2100-19: Purpose To evaluate mask performance; Criteria Level 1 under the conditions of the evaluation; Result Pass
  • EN ISO 11737-1 Bioburden: Purpose To evaluate microbial cleanliness; Criteria Under the conditions of the study, at most 30 CFU/g; Result Pass
  • ISO 10993-5: Purpose To evaluate the cytotoxic potential of the mask; Criteria Under the conditions of the study, non-cytotoxic; Result Pass
  • ISO 10993-10 Sensitization: Purpose To evaluate the sensitization potential of the mask; Criteria Under the conditions of the study, not a sensitizer; Result Pass
  • ISO 10993-10 Irritation: Purpose To evaluate the irritation potential of the mask; Criteria Under the conditions of the study, not an irritant; Result Pass

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K110455

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 878.4040 Surgical apparel.

(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 1, 2024

Owens & Minor (O&M) Halyard, Inc. Caitlin Senter Director. Global Regulatory Affairs 9120 Lockwood Blvd Mechanicsville, Virginia 23116

Re: K232777

Trade/Device Name: FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 16, 2024 Received: May 17, 2024

Dear Caitlin Senter:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

anıl

For Bifeng Qian, M.D., Ph.D. Assistant Director

2

DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K232777

Device Name

FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868), FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)

Indications for Use (Describe)

The FLUIDSHIELD* 1 Procedure Mask(s) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intention control practices to reduce the potential exposure of the wearer to blood and body fluids. FLUIDSHIELD* 1 Procedure Mask(s) are single use, disposable device(s), provided non-sterile.

Type of Use (Select one or both, as applicable)
-------------------------------------------------
Presentation Use (21 CFR 201.66) - Direct to ConsumerSample Compounding (21 CFR 201.66) - Compounding
----------------------------------------------------------------------------------------------------------------------------------------------------------------------

__ Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color, with horizontal lines running through the letters. To the right of the letters is the company name "Owens & Minor" in gray. The ampersand symbol is placed between the two words.

510(k) Summary – K232777

Date of SummaryJuly 1, 2024
510(k) SubmitterO & M Halyard, Inc.
1 Edison Drive
Alpharetta, GA 30005
Primary Contact for thisCaitlin Senter, MS, RAC
510(k) SubmissionTel: 678-221-7330
Email: caitlin.senter@owens-minor.com
Marketed Common NameProcedure Mask
Device Submission Trade
Name and DescriptionFLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops,
Lavender (25868); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT*
Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)
Device Product Code,
Class and
Classification NameFXX
II
Surgical Apparel (21 CFR 878.4040)
Predicate DeviceK110455
Kimberly-Clark KC100 Face Masks
FXX Surgical Mask
Surgical Apparel (21 CFR 878.4040)
Subject Device DescriptionThe subject devices are ASTM F2100 Level 1 (lavender in color) Procedure
Masks. The ASTM F2100 Level 1 Procedure Mask family of products are a
three-layer mask, constructed of well-known non-woven materials used in
facial protection. The FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining
and SO SOFT* Earloops, Lavender (25868) includes a malleable nosepiece. The
FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT*
Earloops, Lavender, Wrap Around Visor (41798) includes a visor and nose
foam.
These masks are single use, disposable devices, provided non-sterile.
Indications for UseThe FLUIDSHIELD* 1 Procedure Mask(s) are intended to be worn to protect both
the patient and healthcare personnel from transfer of microorganisms, body
fluids, and particulate material. These face masks are intended for use in
infection control practices to reduce the potential exposure of the wearer to
blood and body fluids. FLUIDSHIELD* 1 Procedure Mask(s) are single use,
disposable device(s), provided non-sterile.

5

Image /page/5/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color on the left side of the image. To the right of the letters is the name of the company, "Owens & Minor", in a light gray color.

Technological Characteristics Comparison Table
Subject DeviceSubject DevicePredicate DeviceComparison
FLUIDSHIELD* 1
Procedure Mask with SO
SOFT* Lining and SO
SOFT* Earloops, Lavender
(25868)FLUIDSHIELD* 1 Fog-Free
Procedure Mask with
SOO SOFT* Lining and SO
SOFT* Earloops,
Lavender, Wrap Around
Visor (41798)KC100 Face Masks
(K110455)
FDA Product
CodeFXXFXXFXXSame
FDA
ClassificationClass IIClass IIClass IISame
Regulation
Number21 CFR 878.404021 CFR 878.404021 CFR 878.4040Same
Common NameSurgical MaskSurgical MaskSurgical MaskSame
Device Trade
NameFLUIDSHIELD* 1
Procedure Mask with SO
SOFT* Lining and SO
SOFT* Earloops,
Lavender (25868)FLUIDSHIELD* 1 Fog-Free
Procedure Mask with SO
SOFT* Lining and SO
SOFT* Earloops,
Lavender, Wrap Around
Visor (41798)KC100 Procedure
MaskDifferent
Indications for
UseThe FLUIDSHIELD* 1
Procedure Mask(s) are
intended to be worn to
protect both the patient
and healthcare
personnel from transfer
of microorganisms, body
fluids, and particulate
material. These face
masks are intended for
use in infection control
practices to reduce the
potential exposure of the
wearer to blood and
body fluids.
FLUIDSHIELD* 1
Procedure Mask(s) are
single use, disposable
device(s), provided non-
sterile.The FLUIDSHIELD* 1
Procedure Mask(s) are
intended to be worn to
protect both the patient
and healthcare personnel
from transfer of
microorganisms, body
fluids, and particulate
material. These face
masks are intended for
use in infection control
practices to reduce the
potential exposure of the
wearer to blood and
body fluids.
FLUIDSHIELD* 1
Procedure Mask(s) are
single use, disposable
device(s), provided non-
sterile.The Kimberly-Clark
KC100 Face Mask(s)
is intended to be
worn to protect
both the patient
and healthcare
personnel from
transfer of
microorganisms,
body fluids, and
particulate
material. These face
masks are intended
for use in infection
control practices to
reduce the
potential exposure
of the wearer to
blood and body
fluids. The
Kimberly-Clark
KC100 face mask(s)
is a single use,
disposable
device(s), providedSame
The device
trade
names are
different
non-sterile.
Over-the-
Counter /ОТСОТСОТСSame
Prescription
Design Attributes
Number of
Layers333Same
ColorLavenderLavenderYellow, blue, green,
white, lavenderSame
StylePleated with earloopsPleated with earloopsPleated with earloopsSame
Outer LayerSpunbond polypropyleneSpunbond
polypropyleneSpunbond
polypropyleneSame
Middle LayerMeltblown
polypropyleneMeltblown
polypropyleneMeltblown
polypropyleneSame
Inner LayerPolyethylene/polyesterPolyethylene / polyesterPolyethylene /
polyesterSame
BindingsPolyester spunlace /
polyester spunbondPolyester spunlace /
polyester spunbondPolyester spunlace /
polyester spunbondSame
EarloopPolyester/lycraPolyester / lycraPolyester / lycraSame
Nose wirePolyethylene coated steel
wire / malleable
aluminumPolyethylene coated
steel wire / malleable
aluminumAluminum or
polyethylene coated
steelSame
VisorNonePolyester filmIncludes models with
polyester film visor
and models without a
visorSame
Nose FoamNoneBlue polyester foamIncludes models with
blue polyester nose
foam and models
without nose foamSame
Mask
Dimension
Length6.875" ± 0.125"6.875" ± 0.125"6.875" ± 0.125"Same
Mask
Dimension
Width (Flat)3.625" +/-0.125"3.625" +/-0.125"3.625" +/- 0.125"Same
Performance Data/Product Claims
ASTM F2100
Level111Same
EN 14683Type IINoNoDifferent
Single UseYesYesYesSame
SterilityNon-sterileNon-sterileNon-sterileSame
Fluid
Resistance
ASTM F186280 mmHg80 mmHg80 mmHgSame
Particulate
Filtration
Efficiency
ASTM F2299≥ 95%≥ 95%≥ 95%Same
Differential
pressure